Fanapt Labeling Expanded to Include Maintenance Treatment in Schizophrenia

The approval was based on the results of the REPRIEVE study
The approval was based on the results of the REPRIEVE study

The Food and Drug Administration (FDA) has approved updated labeling for Fanapt (iloperidone; Vanda), expanding the prescribing information to describe the drug's effectiveness as a maintenance treatment for adults with schizophrenia. The updated labeling includes long-term efficacy data in which Fanapt was shown to be effective in delaying time to relapse in schizophrenia patients who were stabilized on Fanapt.  

The approval was based on the results of the REPRIEVE (Relapse prevention study in patients with schizophrenia) clinical study which evaluated the efficacy and safety of long-term maintenance of of Fanapt. In the study, 79.6% of Fanapt-treated patients remained relapse free compared to 36.6% for placebo-treated patients.

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Fanapt is an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. The drug should be titrated slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to other therapies that do not require similar titration. Fanapt has also been associated with QT prolongation, which should also be considered before prescribing.

Fanapt is available in 1mg, 2mg, 4mg, 6mg, 8mg, 10mg, and 12mg tablet strengths.

For more information visit Fanapt.com.

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